Clinical Field Study Research Articles

Dexmedetomidine oromucosal gel for noise-associated acute anxiety and fear in dogs—a randomised, double-blind, placebo-controlled clinical study

The aim of this randomised, double-blind, placebo-controlled, clinical-field study was to evaluate the effect of dexmedetomidine oromucosal gel at subsedative doses in alleviation of noise-associated acute anxiety and fear in...

Administration of non-pathogenic isolates of Escherichia coli and Clostridium perfringens type A to piglets in a herd affected with a high incidence of neonatal diarrhoea

A bacterial cocktail of living strains of Clostridium perfringens type A (CPA) without β2-toxin gene and non-pathogenic Escherichia coli was administered orally to newborn piglets before first colostrum intake and on 2 consecutive days on a farm with a high incidence of diarrhoea and antibiotic treatment in suckling piglets associated with E. coli and CPA. This clinical field study was driven by the hypothetic principle of competitive exclusion of pathogenic bacteria due to prior colonization of the gut mucosal surface by non-pathogenic strains of the same bacterial species with the aim of preventing disease. Although CPA strains used in this study did not produce toxins in vitro, their lack of pathogenicity cannot be conclusively confirmed. The health status of the herd was impaired by a high incidence of postpartum dysgalactia syndrome in sows (70%) and a high incidence of neonatal diarrhoea caused by enterotoxigenic E. coli and CPA during the study. No obvious adverse effect of the bacterial treatment occurred. On average, more piglets were weaned in litters treated (P=0.009). Visual pathological alterations in the small intestinal wall were more frequent in dead piglets of the control group (P=0.004) and necrotizing enteritis was only found in that group. A higher average daily weight gain of piglets in the control group (P<0.001) may be due to an increased milk uptake due to less competition in the smaller litters. The bacterial cocktail was tested under field conditions for its potential to stabilize gut health status in suckling piglets before disease development due to colibacillosis and clostridial infections; however, the gut flora stabilizing effect of the bacterial cocktail was not clearly discernible in this study. Further basic research is needed to confirm the positive effects of the bacterial treatment used and to identify additional potential bacterial candidates for competitive exclusion.

Cross-reactive multifunctional CD4+ T cell responses against Salmonella enterica serovars Typhi, Paratyphi A and Paratyphi B in humans following immunization with live oral typhoid vaccine Ty21a

The live oral typhoid vaccine Ty21a elicits predominantly CD8+, as well as CD4+ T cells mediated immune responses. Clinical field studies showed that Ty21a is moderately effective against S. Typhi and S. Paratyphi B, but not S. Paratyphi A infections. In this study we describe the in depth characterization of S. Typhi, S. Paratyphi A and S. Paratyphi B cross-reactive CD4+ T cell responses elicited following immunization with Ty21a. PBMC samples were collected from 16 healthy volunteers before and 42/84days after Ty21a immunization and stimulated ex-vivo with Salmonella-infected targets. Multiparametric flow cytometry was used to detect the vaccine elicited Salmonella-specific responses in T effector/memory (TEM) and CD45RA+ T effector/memory (TEMRA) CD4+ cell subsets, by measuring CD4+ multifunctional (MF) cells that concomitantly produced IFN-γ, TNF-α, IL-2, MIP-1β, IL-17A and/or expressed CD107a. Post-vaccination increases in S. Typhi-specific MF cells were observed in CD4+ TEM and TEMRA subsets which predominantly produced IFN-γ and/or TNF-α, while IL-2 was produced by a smaller cell subset. A small proportion of those MF cells also produced MIP-1β, IL-17A and expressed CD107a (a marker associated with cytotoxicity). Approximately one third of these specific MF cells have the potential to migrate to the gut mucosa, as evidenced by co-expression of the gut-homing molecule integrin α4β7. In contrast to our previous observations with CD8+ T cells, MF CD4+ T cell responses to the different Salmonella serovars evaluated were similar in magnitude and characteristics. We conclude that although induction of cross-reactive CD4+ MF effector T cells suggest a possible role in Salmonella-immunity, these responses are unlikely to provide an immunological basis for the observed efficacy of Ty21a against S. Typhi and S. Paratyphi B, but not to S. Paratyphi A.

Pilot, randomized, placebo-controlled clinical field study to evaluate the effectiveness of bupivacaine liposome injectable suspension for the provision of post-surgical analgesia in dogs undergoing stifle surgery.

BackgroundLocal anesthetics are an important component of perioperative pain management, but the duration of action of available products is limited. We hypothesized that a single local infiltration of a novel bupivacaine liposome injectable suspension (AT-003) would provide clinically effective analgesia over a 72-h period.In a masked, randomized, placebo-controlled, multi-center pilot field study, dogs undergoing lateral retinacular suture placement for cranial cruciate insufficiency were randomly assigned to surgical site infiltration with AT-003 (5.3 mg/kg) or an equivalent volume of saline. Infiltration of the surgical site was done prior to closure. Primary outcome measure was the Glasgow Composite Measure Pain Scale (CMPS-SF) assessed prior to surgery and at 2, 4, 8, 12, 24, 30, 36, 48, 54, 60 and 72 h following surgery by trained individuals. Provision for rescue analgesia was employed. Repeated measures analysis of variance were utilized to test for possible differences between treatment groups and a success/failure analysis was also employed, based on the need for rescue analgesia.ResultsForty-six dogs were enrolled and evaluated. For CMPS-SF scores there was a significant overall treatment effect (p = 0.0027) in favor of AT-003. There were significantly more successes in the AT-003 group compared to placebo over each time period (p = 0.0001 for 0–24 h, p = 0.0349 for 0–48 h, and p = 0.0240 for 0-72 h). No significant adverse events were seen.ConclusionsAT-003 (bupivacaine liposome injectable suspension) provided measurable local analgesia over a 72-h period following post-stifle surgery surgical site tissue infiltration. Further work is indicated to develop this product for clinical use.Electronic supplementary materialThe online version of this article (doi:10.1186/s12917-016-0798-1) contains supplementary material, which is available to authorized users.

Efficacy of afoxolaner in a clinical field study in dogs naturally infested with Sarcoptes scabiei.

The acaricidal efficacy of afoxolaner (NexGard®, Merial) was evaluated against Sarcoptes scabiei var. canis in a field efficacy study, when administered orally at a minimum dose of 2.5 mg/kg to dogs naturally infested with the mites. Twenty mixed-breed dogs of either sex (6 males and 14 females), aged over 6 months and weighing 4–18 kg, were studied in this randomised controlled field efficacy trial. Dogs, naturally infested with Sarcoptes scabiei var. canis confirmed by skin scrapings collected prior to allocation, were randomly divided into two equal groups. Dogs in Group 1 were not treated. Dogs in Group 2 were treated on Days 0 and 28. On Days 0 (pre-treatment), 28 (pre-treatment) and 56, five skin scrapings of similar size were taken from different sites with lesions suggestive of sarcoptic mange. The extent of lesions was also recorded on Days 0, 28 and 56, and photographs were taken. Dogs treated orally with afoxolaner had significantly (p < 0.001) lower mite counts than untreated control animals at Days 28 and 56 with no mites recovered from treated dogs at these times (100% efficacy based on mite counts). In addition, dogs treated with NexGard had significantly (p < 0.05) better lesion resolution at Day 56 than Day 0; no treated dog showed pruritus compared to 7/10 dogs in the control group, 1/9 treated dogs had crusts compared to 5/10 controls and 8/9 dogs recovered 90% of hairs on lesions compared to 0/10 control dogs.

Pilot, randomized, placebo-controlled clinical field study to evaluate the effectiveness of bupivacaine liposome injectable suspension for the provision of post-surgical analgesia in dogs undergoing stifle surgery

Pilot, randomized, placebo-controlled clinical field study to evaluate the effectiveness of bupivacaine liposome injectable suspension for the provision of post-surgical analgesia in dogs undergoing stifle surgery

Colorimetric detection of coxsackievirus A6 by reverse transcription loop mediated isothermal amplification

To develop a simple, rapid and sensitive colorimetric reverse-transcription loop-mediated isothermal amplification (RT-LAMP) for rapid detection of coxsackievirus A6 (CV-A6) based on the colour chang of hydroxy naphthol blue (HNB). The method employed a set of six primers that recognized sequences of VP1 gene for amplification of nucleic acid under isothermal conditions at 63 °C for 50 min. The products were detected through visual inspection of color change by the pre-addition of HNB dye. The specificity was validated by detecting a collection of different human enteroviruses. The sensitivity of this assay was evaluated by serial dilutions of RNA molecules from in vitro transcription of CV-A6 VP1 gene, and compared with real-time RT-PCR (rRT-PCR) in parallel. This assay was evaluated with 92 clinical specimens from patients with hand-foot-mouth disease. A positive color (sky blue) was only observed in the preparation of CV-A6, whereas none of the other 23 kinds of human enteroviruses showed a color change. The HNB based RT-LAMP showed a sensitivity of 100 copies/reaction, which was at the same level as that of the rRT-PCR. The result of RT-LAMP in analysis of 92 clinical specimens was consistent with that of the rRT-PCR. The kappa correlation between the two methods was 1 and both of the sensitivity and specificity of the RT-LAMP assay were 100%. The established RT-LAMP assay had good specificity and sensitivity and thus demonstrated to be a promising screening tool for CV-A6 infection. It also has the potential to be used in resource-limited clinical sites and field study.

A multi-site clinical field study to evaluate the effectiveness of manual cleaning for flexible gastrointestinal endoscopes

An ATP bioluminesce assay (ATP Water Test), measuring organic bioburden including microbes, was used to monitor the cleanliness of flexible GI endoscopes after the manual cleaning step of the decontamination and disinfection process, in seven US hospitals.

Developing a mobile application for recording learning experiences in nursing practice.

In complex clinical on-the-job training a seamless and target-oriented incorporation is crucial to assure a good medical care. The reliable transmission of specific and relevant facts, besides education knowledge, is a key factor to ensure sustainable quality in care processes. We present the clinical field study WITRA care. A possible way to capture hidden clinical care knowledge with assistance of mobile devices will be described. Basic functions to collect learning experiences with mobile devices as well as a secure and confidential manner to support a reliable transmission procedure in the hospital network area are implemented. A user experience questionnaire and a semi-standardized interview illustrate first positive acceptance evaluations and time-saving effects. With mobile devices, tacit knowledge gaps can be tapped in a clinical care unit. The study provided first insights and proved its feasibility in general. However, advanced problems and questions arose and will be considered in the future.

Evaluation of the efficacy of meloxicam for post-operative management of pain and inflammation in horses after orthopaedic surgery in a placebo controlled clinical field trial.

BackgroundThe benefit of pre and post-operative administration of non-steroidal anti-inflammatory drugs for the relief of post-operative pain and control of inflammation in horses following orthopaedic surgery has not been previously investigated in controlled clinical field trials, and the utility of such treatment is a matter of ongoing dispute. Recently the utility of post-operative pain management was emphasized. It was therefore our aim to determine the efficacy of meloxicam in horses following partial resection of fractured splint bones. This condition was selected since the limited extent of the insult and the defined surgical intervention allowed the conduct of a randomized, double blinded, placebo-controlled, parallel group, multi-centre clinical field study in a homogenous patient population.ResultsSixty-six client owned horses requiring unilateral partial splint bone resection were recruited in 15 centres in Germany and were allocated in a 1:1 ratio to receive meloxicam, 0.6 mg/kg for 5 days.Lameness at trot grades prior to surgery were similar in the meloxicam and placebo treatment groups but were significantly lower in the meloxicam group on day 6 post surgery. Clinical scores for soft tissue swelling and assessment of analgesic and anti-inflammatory efficacy by the investigators at the end of the study were significantly better for the meloxicam compared to the placebo group. No treatment-related adverse reactions were observed.ConclusionThe administration of meloxicam i.v. once prior to surgery followed by once daily oral administration for four consecutive days is efficacious for the control of post-operative pain and inflammation in horses undergoing orthopaedic surgery.

HUBUNGAN ASUPAN NATRIUM DENGAN TEKANAN DARAH PADA PEGAWAI DI SMA NEGERI 1 BATANG

Background: Hypertension is a condition where there is an increase in pressure. One of the main causes of hypertension is a lifestyle and a wrong diet. Preserved foods and kitchen salt and high amounts of flavoring can increase blood pressure because they contain excessive amounts of sodium.Objective: To determine the relationship between sodium intake and blood pressure in employees at SMA N 1 Batang.Method: This study was a clinical nutrition field study with a cross sectional approach. The sample was 50 people in SMA N 1 Batang which were determined by random sampling. Data collected in the form of general data samples obtained through the form of collecting data samples, data on sodium intake through a semi-quantitative food frequency form, and blood pressure through measurements using a spignomanometer. Test statistics are used to analyze the relationship between variables using the Pearson Product Moment correlation test.Results: The results showed that 58.0% of the samples had enough sodium intake and 64.0% of the samples had normal blood pressure. The results of statistical tests show that there is a relationship between sodium intake and systolic and diastolic blood pressure with a value of p 0.05.Conclusion: There is a correlation between sodium intake and blood pressure in employees in SMA 1 Batang.

Effects of albendazole on the clinical outcome and immunological responses in helminth co-infected tuberculosis patients: a double blind randomised clinical trial

Despite several review papers and experimental studies concerning the impact of chronic helminth infection on tuberculosis in recent years, there is a scarcity of data from clinical field studies in highly endemic areas for these diseases. We believe this is the first randomised clinical trial investigating the impact of albendazole treatment on the clinical and immunological outcomes of helminth co-infected tuberculosis patients. A randomised, double-blind, placebo-controlled trial of albendazole (400mg per day for 3days) in helminth-positive tuberculosis patients was conducted in Gondar, Ethiopia. The primary outcome was clinical improvement (ΔTB score) after 2months. Among secondary outcomes were changes in the levels of eosinophils, CD4+ T cells, regulatory T cells, IFN-γ, IL-5 and IL-10 after 3months. A total of 140 helminth co-infected tuberculosis patients were included with an HIV co-infection rate of 22.8%. There was no significant effect on the primary outcome (ΔTB score: 5.6±2.9 for albendazole versus 5.9±2.5 for placebo, P=0.59). The albendazole-treated group showed a decline in eosinophil cells (P=0.001) and IL-10 (P=0.017) after 3months. In an exploratory analysis after 12weeks, the albendazole treated group showed a trend towards weight gain compared with the placebo group (11.2±8.5kg versus 8.2±8.7kg, P=0.08)). The reductions in eosinophil counts and IL-10 show that asymptomatic helminth infection significantly affects host immunity during tuberculosis and can be effectively reversed by albendazole treatment. The clinical effects of helminth infection on chronic infectious diseases such as tuberculosis merit further characterisation.

Pharmacokinetics, pharmacodynamics, toxicology and therapeutics of mavacoxib in the dog: a review.

Mavacoxib is a novel nonsteroidal anti-inflammatory drug (NSAID), with a preferential action on the cyclooxygenase (COX)-2 isoform of COX and a long duration of action. It is classified chemically as a member of the sulphonamide subgroup of coxibs. Mavacoxib is highly lipid but very poorly water soluble. In the dog, the pharmacokinetic (PK) profile comprises very slow body clearance, long elimination half-life and a relatively large distribution volume. Biotransformation and renal excretion are very limited, and elimination occurs primarily by biliary secretion and excretion of unchanged drug in faeces. The PK profile of mavacoxib differs quantitatively between young healthy dogs (Beagles and mongrels) and clinical cases with osteoarthritis (OA). In OA dogs, mavacoxib exhibits a much longer terminal half-life, associated principally with their greater median body weight compared with dogs used in preclinical studies. There is also some evidence of breed differences and a small effect of age on mavacoxib PK in the OA canine population. The pharmacodynamics (PD) of mavacoxib has been established: (i) in whole blood assays at the molecular level (inhibition of COX-1 and COX-2 isoforms); (ii) in preclinical models of inflammation and pain; and (iii) in clinical OA subjects treated with mavacoxib. The dosage schedule of mavacoxib for clinical use has been determined by owner and veterinary clinical assessments and is supported by integration of PK and PD preclinical data with clinical responses in canine disease models and in dogs with naturally occurring OA. The dosage regimen has been further confirmed by correlating levels of inhibition of COX isoforms in in vitro whole blood assays with plasma concentrations of mavacoxib achieved in OA dogs. In addition to the specific properties of mavacoxib, some general aspects of the PK and PD of other agents of the NSAID group, together with pathophysiological and clinical aspects of OA, are reviewed, as a basis for correlating with the safety and efficacy of mavacoxib in therapeutic use. Integration of PK and PD data suggests that the recommended dosage regimen of 2 mg/kg bw once for 14 days, followed by administration at monthly intervals, is optimal from both efficacy and safety perspectives and is further confirmed by clinical field studies.

Mental distress and effort to engage an image-guided navigation system in the surgical training of endoscopic sinus surgery: a prospective, randomised clinical trial.

The use of image-guided navigation systems in the training of FESS is discussed controversy. Many experienced sinus surgeons report a better spatial orientation and an improved situational awareness intraoperatively. But many fear that the navigation system could be a disadvantage in the surgical training because of a higher mental demand and a possible loss of surgical skills. This clinical field study investigates mental and physical demands during transnasal surgery with and without the aid of a navigation system at an early stage in FESS training. Thirty-two endonasal sinus surgeries done by eight different trainee surgeons were included. After randomization, one side of each patient was operated by use of a navigation system, the other side without. During the whole surgery, the surgeons were connected to a biofeedback device measuring the heart rate, the heart rate variability, the respiratory frequency and the masticator EMG. Stress situations could be identified by an increase of the heart rate frequency and a decrease of the heart rate variability. The mental workload during a FESS procedure is high compared to the baseline before and after surgery. The mental workload level when using the navigation did not significantly differ from the side without using the navigation. Residents with more than 30 FESS procedures already done, showed a slightly decreased mental workload when using the navigation. An additional workload shift toward the navigation system could not be observed in any surgeon. Remarkable other stressors could be identified during this study: the behavior of the supervisor or the use of the 45° endoscope, other colleagues or students entering the theatre, poor vision due to bleeding and the preoperative waiting when measuring the baseline. The mental load of young surgeons in FESS surgery is tremendous. The application of a navigation system did not cause a higher mental workload or distress. The device showed a positive effort to engage for the trainees with more than 30 FESS procedures done. In this subgroup it even leads to decreased mental workload.

Experimental Models of Microvascular Immunopathology: The Example of Cerebral Malaria.

Human cerebral malaria is a severe and often lethal complication of Plasmodium falciparum infection. Complex host and parasite interactions should the precise mechanisms involved in the onset of this neuropathology. Adhesion of parasitised red blood cells and host cells to endothelial cells lead to profound endothelial alterations that trigger immunopathological changes, varying degrees of brain oedema and can compromise cerebral blood flow, cause cranial nerve dysfunction and hypoxia. Study of the cerebral pathology in human patients is limited to clinical and genetic field studies in endemic areas, thus cerebral malaria (CM) research relies heavily on experimental models. The availability of malaria models allows study from the inoculation of Plasmodium to the onset of disease and permit invasive experiments. Here, we discuss some aspects of our current understanding of CM, the experimental models available and some important recent findings extrapolated from these models.

Field clinical study evaluating the efficacy and safety of an oral formulation containing milbemycin oxime/praziquantel (Milbemax®, Novartis Animal Health) in the chemoprevention of the zoonotic canine infection by Dirofilaria repens.

BackgroundDirofilaria repens is the causative agent of subcutaneous dirofilariosis of dogs, other animals and humans. This nematode is transmitted by mosquitoes of Aedes, Anopheles and Culex genera. In dogs, the parasite may cause subclinical infection or cutaneous signs. Recently, D. repens has emerged and spread in different geographical areas, with an increase of cases in dogs and humans. Chemoprevention in dogs in endemic areas is the most reliable approach for controlling this infection. This paper describes a randomized, blocked and multicentric clinical field study investigating the efficacy of an oral, chewable formulation containing milbemycin oxime/praziquantel (Milbemax®, Novartis Animal Health) in the chemoprevention of subcutaneous dirofilariosis in dogs.MethodsThis study was conducted in endemic areas of Italy. A total of 249 dogs, at two sites, negative for D. repens, were allocated into two groups (i.e. Treated -T1 vs Untreated-T2) with a ratio of 1:1, and subjected to clinical visits and blood sampling once monthly until the end of the study. All blood samples were microscopically and genetically examined. Animals belonging to T1 group received a minimum target dose of 0.5 mg/kg bodyweight of milbemycin oxime and 5 mg/kg of praziquantel in commercial tablets (Milbemax®) according body weight once every 4 weeks. Animals of group T2 were not treated with Milbemax® but received, when necessary, specific parasiticide treatments. The study duration was 336 ± 2 days for each dog.ResultsA total of 219 dogs completed the study (i.e. 111 in T1 and 108 in T2), while 30 dogs (i.e. 13 in T1, 17 in T2) were withdrawn for a variety of reasons unrelated to administration of Milbemax®. The percentages of animals not showing microfilariae of D. repens were 100% (111 animals) in T1 and 94.7% (108 animals out of 114) in group T2. Milbemax® was shown to be safe in treated dogs.ConclusionsThe results of this study confirm that the monthly use of Milbemax® in dogs is effective and safe for the prevention of subcutaneous dirofilariosis in endemic areas.

BCG vaccination reduces risk of tuberculosis infection in vaccinated badgers and unvaccinated badger cubs.

Wildlife is a global source of endemic and emerging infectious diseases. The control of tuberculosis (TB) in cattle in Britain and Ireland is hindered by persistent infection in wild badgers (Meles meles). Vaccination with Bacillus Calmette-Guérin (BCG) has been shown to reduce the severity and progression of experimentally induced TB in captive badgers. Analysis of data from a four-year clinical field study, conducted at the social group level, suggested a similar, direct protective effect of BCG in a wild badger population. Here we present new evidence from the same study identifying both a direct beneficial effect of vaccination in individual badgers and an indirect protective effect in unvaccinated cubs. We show that intramuscular injection of BCG reduced by 76% (Odds ratio = 0.24, 95% confidence interval (CI) 0.11–0.52) the risk of free-living vaccinated individuals testing positive to a diagnostic test combination to detect progressive infection. A more sensitive panel of tests for the detection of infection per se identified a reduction of 54% (Odds ratio = 0.46, 95% CI 0.26–0.88) in the risk of a positive result following vaccination. In addition, we show the risk of unvaccinated badger cubs, but not adults, testing positive to an even more sensitive panel of diagnostic tests decreased significantly as the proportion of vaccinated individuals in their social group increased (Odds ratio = 0.08, 95% CI 0.01–0.76; P = 0.03). When more than a third of their social group had been vaccinated, the risk to unvaccinated cubs was reduced by 79% (Odds ratio = 0.21, 95% CI 0.05–0.81; P = 0.02).

SICKLE CELL ANAEMIA AND MALARIA

Sickle cell anaemia is a major chapter within haemolytic anaemias; at the same time, its epidemiology is a remarkable signature of the past and present world distribution of Plasmodium falciparum malaria. In this brief review, in keeping with the theme of this journal, we focus on the close and complex relationship betweeen this blood disease and this infectious disease. On one hand, heterozygotes for the sickle gene (AS) are relatively protected against the danger of dying of malaria, as now firmly established through a number of clinical field studies from different parts of Africa. In addition, experimental work is consistent with a plausibile mechanism: namely, that in AS heterozygotes P falciparum-infected red cells sickle preferentially and are then removed by macrophages. On the other hand, patients who are homozygous for the sickle gene and therefore suffer from sickle cell anaemia (SCA) are highly susceptible to the lethal effects of malaria. The simplest explanation of this fact is that malaria makes the anaemia of SCA more severe; in addition, in SCA there is often hyposplenism, which reduces clearance of parasites. From the point of view of public health it is important that in malaria-endemic countries patients with SCA, and particularly children, be protected from malaria by appropriate prophylaxis.

Prevention of Floppy Kid Syndrome: A long-term clinical field study conducted on a goat farm in South Tyrol/Italy

ObjectiveTo discover whether Floppy Kid Syndrome can be prevented by separating kids at birth from their dams and rearing them on bovine colostrum followed by cows’ milk. DesignClinical field study during the period of 2000–2010. Materials and methodsThe study was conducted on a goat farm in South Tyrol, Italy. Kids were separated at birth from their dams and reared on bovine colostrum followed by cows’ milk (group 1); kids were also reared traditionally leaving them to suckle with their respective dams (group 2). In both groups, clinical symptoms were recorded. In those exhibiting FKS, associated symptoms and recovery after treatment were documented. Cumulative probability of survival and determination of hazard rate were plotted using the Kaplan–Meier method. ResultsA total of 414 kids born on this farm over this period (2000–2010) were examined. None of the 146 kids of group 1 acquired FKS. In group 2, 16 from the 268 kids reared traditionally developed typical FKS. The symptoms of FKS, which were observed included altered general condition (apathy, somnolence, and lethargy), altered posture (knuckling over in the carpal joints, ataxia, and recumbency), salivation and abomasal distension. The difference between the groups was significant (χ2 test, p=0.003). Distribution of FKS in group 2 revealed that in January and February no cases of FKS occurred. In March, April, and May morbidity was at 2.6%, 69.2%, and 71.4%, respectively. Survival analysis in group 1 revealed a cumulative probability of survival of 1.00 and a hazard rate of 0.00 during the whole observation period (January to May). In group 2, a cumulative probability of survival of 1.00 for the first two days after birth, declining to 0.94 on the 11th day, was demonstrated. The difference in time between the groups was significant (p=0.003) applying the Log Rank test. In group 2, for the period of March to May survival analysis revealed a cumulative probability of survival of 1.00 for the first day after birth, declining to 0.84 on the 11th day. This indicates a morbidity rate of 16% for this period. On the 4th and 5th day post partum the hazard rate was highest (HR=0.04). After 11 days neither cumulative probability of survival nor hazard rate declined. The results of this study demonstrate an 100% probability that FKS will not affect kids after 11 days of age. A positive correlation was apparent between the recorded outdoor temperature and the incidence of Floppy Kid Syndrome. Conclusions and clinical relevanceIn this long-term study conducted on a goat farm in South Tyrol Floppy Kid Syndrome in goat kids can be prevented by separating neonate kids from the dams, and rearing the kids with bovine colostrum/milk. The important factor seems to be the separation of new born kids from adults, thus preventing exposure of kids via sucking/licking to the bacterial agent causing d-lactic acidosis, originating from the adult goats or their immediate environment. Greatest susceptibility for Floppy Kid Syndrome is in the period from March to May between the 3rd and 6th day post partum.

Efficacy of a Barrier Gel for Reducing the Development of Plaque, Calculus, and Gingivitis in Cats

This study was performed to assess the field efficacy of a professional and home-care barrier gel against the development of plaque, calculus, gingival bleeding, and gingivitis in client-owned cats over a 56-day period compared with negative controls. In a randomized, negative-controlled, outcome evaluator-blinded, client-owned animal clinical field study, 31 cats were evaluated to assess if the barrier gel dental product was effective in cats. Following an enrollment-qualification assessment and enrollment of each cat, all cats received a professional dental cleaning, including polishing and irrigation. Following cleaning, a post-cleaning assessment was performed by the evaluator. Then, using a pre-developed randomization schedule, cats were assigned to the treated or control group. The professional version of the barrier gel was applied to the treated group on day 0. The negative-control group patients did not receive any applications of the barrier gel following dental cleaning. Treated-group cats were brought back to the clinic for subsequent applications of the home-care version of the barrier gel, applied by a non-blinded trained assistant. The home-care version product applications began on day 14 and then were applied weekly (days, 21, 28, 35, 42, 49 and 56) through day 56. All cats enrolled in the study underwent full oral examinations and assessments by the blinded evaluator on or about their respective days 28 and 56. At these evaluations, the evaluator performed standardized assessments for plaque, calculus, gingivitis, and gingival bleeding. Numeric scores were assigned for each assessment using predetermined target teeth to ensure consistency. Using these assessment scores, statistical analyses were performed to determine the efficacies against plaque and calculus deposition; additionally, measurements of gingivitis and gingival bleeding were assessed. Change in plaque score from baseline, for all teeth assessed (all 4 canine teeth, and all 4 [corrected] premolar teeth), was significantly (P < 0.05) lower for treated cats than for control cats for both left side average and right side average on day 56. No statistical differences were seen for calculus, gingivitis, or gingival bleeding in this study. In cats with a history of developing plaque, application of the barrier gel dental product following dental cleaning reduced plaque deposition (P < 0.05) compared with control cats.